Fake drugs: Using Baseline Spectral Fingerprinting and a sorting algorithm to infer quality of medications

Area of Science:

• Pharmaceutical analysis
• Analytical chemistry
• Public health

Background:

• A significant percentage of medications in low-income countries and conflict zones are substandard or counterfeit.
• Weak regulatory oversight contributes to the prevalence of poor-quality pharmaceutical stocks.
• There is a critical need for accessible drug quality testing methods in resource-limited settings.

Purpose of the Study:

• To develop and validate a point-of-care method for assessing pharmaceutical stock quality.
• To introduce Baseline Spectral Fingerprinting and Sorting (BSF-S) as a novel quality control technique.
• To address the challenge of counterfeit and low-quality drugs in vulnerable regions.

Main Methods:

• Baseline Spectral Fingerprinting and Sorting (BSF-S) utilizes unique UV spectral profiles of compounds in solution.
• The method incorporates the ELECTRE-TRI-B sorting algorithm to manage sample concentration variations.
• Algorithm parameters were trained using authentic, low-quality, and counterfeit drug samples in a laboratory setting.

Main Results:

• The BSF-S method demonstrated high specificity and sensitivity in classifying drug samples.
• A case study involving 50 Praziquantel samples, including authentic and inauthentic ones, validated the method.
• Researchers, blinded to sample authenticity, confirmed the method's accuracy in sorting samples.

Conclusions:

• The developed BSF-S method offers a reliable approach for point-of-care drug quality assessment.
• Combined with a portable UV device, BSF-S can be a low-cost solution for combating counterfeit medications.
• This technology has the potential to significantly improve medication safety in low-income countries and conflict states.